现行

SN/T 3062.4-2011

进口医疗器械灭菌包装 第4部分：材料和预成型无菌屏障系统要求
Packaging materials for terminally sterilized medical devices for import-Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

2011-09-09

现行

SN/T 3061-2011

进口医疗器械灭菌包装检验操作规程
Rules of the inspection of packaging for import terminally sterilized medical devices

2011-09-09

现行

SN/T 3062.2-2011

进口医疗器械灭菌包装 第2部分：纸袋-要求和试验方法
Packaging materials for terminally sterilized medical devices for import-Part 2:Paper bags-Requirements and test methods

2011-09-09

现行

YY/T 0698.2-2022

最终灭菌医疗器械包装材料　第2部分：灭菌包裹材料　要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods

2022-10-17

现行

YY/T 0698.7-2009

最终灭菌医疗器械包装材料　第7部分：环氧乙烷或辐射灭菌　无菌屏障系统生产用可密封涂胶纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods

2009-06-16

现行

KS P ISO 11607-1

최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및 포장 시스템에 대한 요구사항
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求

2021-06-28

现行

KS P ISO 11607-1

최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및포장 시스템에 대한 요구사항
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求

2018-11-05

现行

AAMI/ISO 11607-1-2019

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
最终灭菌医疗器械的包装第1部分:材料、无菌屏障系统和包装系统的要求

现行

ISO 11607-1-2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求

2019-01-31

现行

GB/T 19633.1-2015

最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

2015-12-10

现行

YY/T 0698.8-2009

最终灭菌医疗器械包装材料　第8部分：蒸汽灭菌器用重复性使用灭菌容器　要求和试验方法
Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods

2009-06-16

现行

SN/T 3062.3-2011

进口医疗器械灭菌包装 第3部分：透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法
Packaging materials for terminally sterilized medical devices for import-Part 3:Sealable pouches and reels of porous materials and plastic film construction-Requirements and test methods

2011-09-09

现行

BS EN 868-9-2018

Packaging for terminally sterilized medical devices-Uncoated nonwoven materials of polyolefines. Requirements and test methods
最终灭菌医疗器械的包装 聚烯烃无涂层非织造材料 要求和试验方法

2019-01-09

现行

BS EN 868-10-2018

Packaging for terminally sterilized medical devices-Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
最终灭菌医疗器械的包装 聚烯烃粘合剂涂层非织造材料 要求和试验方法

2019-01-09

现行

YY/T 0698.4-2009

最终灭菌医疗器械包装材料　第4部分：纸袋　要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods

2009-06-16

现行

UNE-EN 868-9-2009

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
最终灭菌医疗器械的包装.第9部分:聚烯烃的无涂层非织造材料.要求和试验方法

2009-12-02

现行

UNE-EN ISO 11607-1-2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求（ISO 11607-1-2006）

2009-10-14

现行

YY/T 0698.6-2009

最终灭菌医疗器械包装材料　第6部分：用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods

2009-06-16

现行

ISO 11607-1-2019/Amd 1-2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
最终灭菌医疗器械的包装第1部分:材料、无菌屏障系统和包装系统的要求修改件1:风险管理的应用

2023-09-13

现行

UNE-EN 868-10-2009

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
最终灭菌医疗器械的包装.第10部分:聚烯烃粘合剂涂层非织造材料.要求和试验方法

2009-12-02